This is a multicenter, prospective, single-arm, phase 2 clinical trial designed to evaluate the therapeutic efficacy of the NACI (neoadjuvant chemotherapy plus Camrelizumab) for PD-L1-negative locally advanced cervical cancer.
FIGO 2018 stage IB3, IIA2, or IIB/IIIC1r (tumor size>4cm) cervical cancer and without any treatment (After undergoing gynecological examinations by two associate chief physicians or above, the staging of the patients was determined);
Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. In principle, the size of the lesion as shown by the magnetic resonance imaging examination is used as the criterion.
Histologically confirmed squamous carcinoma, adenocarcinoma (common type) or adenosquamous carcinoma of the cervix;
Negative PD-L1 expression on preoperative pathological examination (Combined positive score < 1);
Active, known, or suspected autoimmune disease, or a history of an autoimmune disease, except for the following: vitiligo, alopecia areata, Graves's disease, psoriasis, or eczema that has not required systemic therapy within the last 2 years, hypothyroidism that is asymptomatic or requires only stable doses of hormone replacement therapy (due to autoimmune thyroiditis), type 1 diabetes that requires only stable doses of insulin replacement therapy, asthma that subsides completely in childhood and does not require intervention in adulthood, or diseases that do not recur in the absence of external triggers;
Prior treatment with immune checkpoint inhibitors, including, but not limited to, other anti-PD-1, anti-PD-L1 antibodies, CTLA-4 antibodies, or antibodies against immune co-stimulators (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), or any other therapy targeting a tumor's immune mechanism of action;
Known hypersensitivity to any component and/or any excipient of the trial prescribed medication;
Immunosuppressive drugs or systemic corticosteroids for immunosuppression (> mg/day of prednisone or other equivalent) within 2 weeks prior to trial dosing; topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are permitted;
Single group
Camrelizumab
Drug200 mg, intravenously, 20-60 min. 2 times, every 21 days
Paclitaxel-albumin
Drug260 mg/m² over 30 min, 3 times, every 21 days
Cisplatin
Drug4 h, 75-80 mg/m², 3 times, every 21 days
radical surgery
Procedure/SurgeryRadical hysterectomy + pelvic lymphadenectomy 士 para-aortic lymphadenectomy
Pathologic complete response
Pathologic complete response (pCR) refers to the absence of invasive/in situ cancer in the uterine cervix and/or lymph nodes
Surgical Complications
Intraoperative bleeding, vascular injuries, bladder injuries, rectal injuries, and ureteral injuries were measured by the need for suture repair; occlusive nerve injuries were measured by complete severance, and vascular injuries required documentation of the site of injury. Postoperative complications included: cervical stenosis, cervical insufficiency, ureteral/bladder/rectal/vaginal fistula, internal hemorrhage, pelvic infection, lymphocyst, lymphatic fistula, lower extremity edema, lower extremity venous thrombosis, urinary retention, nerve injury, and bowel obstruction.
Objective response rate
the proportion of patients who had either complete response or partial response, assessed by independent central reviewers according to RECIST, version 1.1.
Positive surgical margin rate
A positive surgical margin means that cancer cells are present at the edge of the resection specimen.
event-free survival
Event-free survival (EFS) refers to the possibility of experiencing a defined set of events (including progression such as metastasis, death, etc.) following NACI treatment.
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Tongji Hospital
Lead sponsor
Southwest Hospital, China
Collaborator
Women's Hospital School Of Medicine Zhejiang University
Collaborator
Anhui Provincial Cancer Hospital
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Gansu Provincial Maternal and Child Health Care Hospital
Collaborator
Beijing Friendship Hospital
Collaborator
Tianjin Medical University General Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
West China Second University Hospital
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Zhejiang Cancer Hospital
Collaborator
Shengjing Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
Cancer Hospital of Guangxi Medical University
Collaborator
